EN 550:1994

Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization

1.1 This European Standard specifies the requirements for the development, validation, process control and monitoring of the sterilization of medical devices using ethylene oxide.   Note: Specifications for sterilizers are being prepared by CEN/TC 102.  1.2 This European Standard does not describe a quality assurance system for the control of all stages of manufacture.   Note: Attention is drawn to the standards for quality systems (see EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system are required and these are normatively referenced at appropriate places in the text.   1.3 This European Standard does not cover operator safety (see note).   Note: Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the existence in some countries of national regualtions laying down safety requirements for handling ethylene oxide and for premises in which it is used.  1.4 This European Standard does not cover the level of residual ethylene oxide within medical devices.   Note: Attention is drawn to the existence in some countries of standards stipulating the level of ethylene oxide residue within medical devices.

Sterilisation von Medizinprodukten - Validierung und Routineüberwachung für die Sterilisation mit Ethylenoxid

Die Europäische Norm legt die Anforderungen an die Entwicklung, Validierung, Verfahrensregelung und Überwachung der Sterilisation von Medizinprodukten mit Ethylenoxid fest.

Stérilisation de dispositifs médicaux - Validation et contrôle de routine pour la stérilisation à l'oxyde d'éthylène

La présente Norme Européenne ne traite pas du système d'assurance de qualité nécessaire pour maîtriser toutes les phases de fabrication.

Sterilizacija medicinskih pripomočkov - Validacija in redni nadzor sterilizacije z etilenoksidom

General Information

• Status: Withdrawn
• Publication Date: 29-Jun-1994
• Withdrawal Date: 30-Apr-2007
• ICS: 11.080 - Sterilization and disinfection
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-May-2007
• Completion Date: 01-May-2007
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN 550:2000 - Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization

Relations

• Replaced By: EN ISO 11135-1:2007 - Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.HWLOHQRNVLGRPSterilisation von Medizinprodukten - Validierung und Routineüberwachung für die Sterilisation mit EthylenoxidStérilisation de dispositifs médicaux - Validation et contrôle de routine pour la stérilisation a l'oxyde d'éthyleneSterilization of medical devices - Validation and routine control of ethylene oxide sterilization11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:Ta slovenski standard je istoveten z:EN 550:1994SIST EN 550:2000en01-januar-2000SIST EN 550:2000SLOVENSKI
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SIST EN 550:2000



SIST EN 550:2000



SIST EN 550:2000



SIST EN 550:2000



SIST EN 550:2000



SIST EN 550:2000



SIST EN 550:2000



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